Making Pharmaceuticals

Supported by:

National Conference Centre, Birmingham

26-27 April 2016

Exhibition & Conference

Register now at www.making-pharma.com@makingpharma

FREE to Attend

Research to Finished Product70+ Seminars & Workshops

90+ Exhibitors

A.J. Tyzack & Co.Adelphi Healthcare PackagingAlexanderwerkAllied Pharma ALMAC ALS (UK) LLP Amphenol Advanced Sensors

GermanyAntech UK & IrelandAPP ElectronicsAsh ScientificAstech IT Solutions Azbil Telstar UK Azelis UK Life SciencesAZO LIquidsBecton Dickinson UKBiogrundBosch Packaging TechnologyBritish Contract Manufacturers

and Packers AssociationBroughton SoftwareButterworth Laboratories Caleva Process SolutionsCIMLOGICClarity Compliance SolutionsCustom PharmaceuticalsDaraDec UK EcolabEdwards AnalyticalEMS Particle Solutions UKEXCiPACTExtract TechnologyFitzpatrick

Fleet LaboratoriesFormpipeFrewittGB Festo UKGEAGerteisInnopharma LabsInternational Society for

Pharmaceutical EngineeringInternational Laboratory ServicesInstitution of Mechanical EngineersIPEC EuropeKAYEKG PharmaKerry IngredientsLabocontroleLabtexLake Life SciencesLa Tene MapsLGCLovibond TintometerManufacturing ChemistMG2Molins TechnologiesMüllerNetzsch Mastermix NotterO’Hara TechnologiesOrigin PackagingOrthos EngineeringPackaging Coordinators Inc.PAP ServicesPharmaterialsPharma Machinery

PharmigPiNKPorvair Filtration Group PPMAProCepTQCLQuadro EngineeringQuality ContextReading Scientific ServicesRiva EuropeS3 ProcessSEPPIC Air Liquide Healthcare

Speciality IngredientsShin Etsu Pharma & Food Materials

DistributionSmithers Pira and Smithers Rapra Staubli (UK) Connectors DivisionStaubli (UK) Robotics DivisionSurfachemSTERIS CorporationSynergy HealthTeknomek Trinity ScientificThe Institute of Clinical ResearchUbichemVaisala OyjVeolia Water TechnologiesVMIWheaton UK Wickham LaboratoriesYgrosYtron-Quadro (UK)Ytron Process Technology

The ExhibitionThe UK Pharmaceutical market is ripe for growth; it’s a great time to be part of the industry, but your strategy needs to be right. Making Pharmaceuticals can help.Please visit the web site to register, to qualify for benefits, and for everything else you need to know.

Just some of this year’s exhibitors

For the latest programme and to register online, visit www.makingpharma.com

Source Manufacture Outsource

Making Pharmaceuticals is designed to help industry improve manufacturing processes, address product formulation / reformulation, reduce undesired variability, deliver consistent product quality, improve process robustness and enhance efficiency.

Research to Finished Product

Making Pharmaceuticals is the only event in the UK dedicated to the detailed and complex issues associated with testing, sourcing, manufacturing, outsourcing and delivering consistent products to the pharmaceutical market.

During the 2-day period of Making Pharmaceuticals, visitors are able to attend a series of seminars compiled by a number of leading authorities in the UK.

Making Pharmaceuticals, is designed to bring together everyone involved in the product development life cycle, leading to commercial manufacturing of pharmaceuticals, and provides an essential focus for the many different skills, and range of expertise necessary to deliver consistent products.

Making Pharmaceuticals provides a forum that will help attendees to solve current challenges, and to prepare for the ones to come.

IdeasInformationAnswers

The attendee profile includes:• Chemists & Formulators• Consultants• Engineers / Engineering• Importers• Management• Marketing & Business Development• Microbiologists• QA/QC• Qualified Persons• Production• Process Development• Regulatory• Validation Disciplines

FREE There is no fee to attend the

exhibition, seminars or workshops

Programme sponsored by:

Media Partners:

Butterworth is a UK based contract laboratory supporting the global pharmaceutical industry. Specialising in the quality control analysis of excipients, API, drug product, packaging and medical devices using recognised international standards, we also develop and validate methods to be used for quality control purposes using a wide range of techniques.

2016 features a focus upon Ingredients and Ingredient suppliers to the Pharmaceutical industry:-

• Two full days of dedicated ingredient conference content

• Sessions presented by key supporting organisations; IPEC Europe and EXCiPACT

Exhibitor presentations:• Azelis• Biogrund• Shin Etsu• Kerry Ingredients• SEPPIC• ALMAC• RSSL

(EPI) Excipients and Pharmaceutical Ingredients at Making Pharmaceuticals

Register in Advancewww.makingpharma.com

Programme sponsored by:

26 April REGULATORY09.15 Regulatory Snakes & Ladders - Navigating Pitfalls of

Pharmaceutical Development Matthew Burton, Jenson R+ Limited

09.35 European Falsified Medicines Directive – Securing the Supply Chain Paul Martin, Aegate

09.55 New Product - Compliance Future Proofing David Thomas, Clarity Compliance

CLINICAL TESTING11.30 The Big Bang Theory: Combining Earned Value, Agile

Project Management and Principle Agent Theory for Clinical Trials Roger Joby, ICR

11.50 What’s Changing with ICH-GCP Dr Alison Messom, ICR

12.10 The Clinical Trial Regulation in a Nutshell Mark Richardson, ICR

DATA MANAGEMENT14.00 An Introduction to the GxP Cloud: Risks, Regulatory

Considerations and Vendor Assessment Keith Williams, Formpipe

14.20 The Path to Predictability in Life Science Supply Chains Sean Robinson, Astec IT Solutions

14.40 OEE /SPC with Operational Excellence Garry Smith, CIMLogic

WORKSHOP15.45 Cross-Industry Innovation for Pharma and Healthcare

iFormulate, Dr Jim Bullock, Dr Malcom McKechnie, Dr David Calvert

26 April INGREDIENTS / EXCIPIENTS09.15 How the EXCiPACT Certification Scheme Helps You

Comply with the Ascertaining GMP for Excipients Guidelines EXiPACT

09.35 How the EXCiPACT™ Certification Scheme is Helping Excipient Suppliers With the Increasing Demands for Audits: - the Suppliers’ View EXiPACT

09.55 How the EXCiPACT™ Certification Scheme is Helping Excipient Suppliers With the Increasing Demands for Audits: - the Users’ View EXiPACT

12.00 Aqueous Ready-To-Use Film Coating Formulation Based on HPMC-AS Dr Mahmud Yunis, Biogrund

14.00 Novel Excipients from Kerry for Product Development Szilard Borbely, Kerry Ingredients

14.20 Skin Feel Modification for Topical Formulations Richard Summers, Azelis

14.40 Applications Using a Multi Functional Excipient, L-HPC Shilpa Mistry, Shin Etsu

15.45 Dermopharmacy Kathleen Allain, SEPPIC

27 April INGREDIENTS / EXCIPIENTS09.15 EU GMP Risk Assessment for Excipients

Kevin Hughes, Colorcon Limited09.35 Implementation of ICH Q3D

Andrew Teasdale, AstraZeneca09.55 FDA Inactive Ingredient Database

Liz Meehan, AstraZeneca

11.30 Characterisation of Pharmaceutical Powders from the Nanoscale to the Macroscale Ross Blezard, Reading Scientific Services Ltd (RSSL)

11.50 Crystallisation of Pharmaceutical Compounds - The Chemists’ Role in Protecting Intellectual Property Aeri Park, Almac

12.10 Film - Coating Kathleen Allain, SEPPIC14.00 Solid Dispersion Using Cellulose Derivatives

Shilpa Mistry, Shin Etsu 14.20 Utilising Excipient Technologies for Greater Patient

Benefits Enosh Mwesigwa, Azelis

26 April MICROBIOLOGY AND PHARMA09.15 Factors to Consider When Designing a Disinfectant

Efficacy Test Rachel Blount, Ecolab Contamination Control

09.45 Microbiological Aspects of Risk Assessment in the Plant Andy Martin, ABM Consulting Ltd

11.30 An Approach tp Process Development pf PMDI’s Using Cold Fill and Pressure Fill Technology Steve Haswell, 3M UK PLC

11.50 Manufacturing Risk Identification in Facilities Shared for Different Products: a Toxicologist’s Viewpoint Chris Collins, Q Scientific Consulting Ltd

12.10 Closures Advantaged Technology, Managing Closures on the Filling Line Process Stepano Beni, Cristina Testoni, Allied Pharma

14.00 Sterile Process Connections Craig Forrester, Staubli (UK) Limited

14.30 True Cost of Water Kalpesh Shah, Veolia Water Technologies

15.45 Serialisation Grainne Hughes, ALMAC16.05 Early Access to Innovative New Medicines

– A Continually Evolving Environment Mark Corbett, Consultant

16.25 Update on Annex 16; Certification by QP and Batch Release Mukesh Patel, CommQP Pharmaceuticals Services Ltd

27 April PHARMACEUTICAL ENGINEERING09.15 Data Integrity – The Current Regulatory Position

and GAMP® Perspective Chris Clark, Ten Ten Ten Consultancy

11.30 The Use of ISPE Base Guidelines in Achieving Cost Effective GMP Compliance Rob Walker, ISPE

PACKAGING14.00 Innovative Ways to Ensure Safety for Children and

Provide Senior-Friendly Solutions Stephen Wilkins, CEO, Child-Safe Packaging Group

14.20 Putting the Patient First - Patient-Friendly Packaging Phill Marley, Packaging Intelligence Manager, AstraZeneca

15.00 The Latest Developments, Technologies and Strategies in Anti-Counterfeit and Tamper-Resistant Packaging Andrew Love, VP Capability Development, Be4ward Ltd

15.20 Developing Your Serialisation Strategy – Key Learnings Andy Cumming, Managing Consultant Be4ward Ltd

26 April OPERATIONAL EXCELLENCE09.15 The Supply Chain and the Impact of Operational

Excellence Claire Edwards, GSK09.35 Operational Readiness Leading to Excellence

Adrian Mills, Strategic Projects and Engineering Solutions Limited

09.55 Effective Equipment Reliability in FMCG Marcus Valance, Alicia Sanchez Espin, GSK

11.30 Contamination Control Chris Hurst, GSK11.50 Avoidance of Physical Contamination

David McFarland, GSK12.10 Contamination Control TBA

PROCESSING14.00 Front End FactoryTBA14.20 The Serialisation Solution - What Does it Offer to

Continuous Processing?TBA14.40 Continuous Processing and Related DisciplinesTBA

QUALITY CONSIDERATIONS15.45 Avoid Deviations TBA16.05 The Importance of Containment Ian Skinner, Skinner

Associates Ltd16.25 Human Factors

Karen Stevenson, GSK

27 April NEW TECHNOLOGIES09.15 Innovation in Processing Darren Ragheb, Centre for

Process Innovation 09.35 Granule Size Distribution of Roller Compaction Process

Riyadh Al Alsady, Sheffield University09.55 Development and Implementation of In Vitro Methods

Wickham Laboratories11.30 Process Microfiltration in the Pharmaceutical Industry;

Processes, Validation and Economics Porvair Fitration Group

12.00 Binary Ionization Technology Simon Bailey, Azbil Telstar UK

BIOSIMILARS14.00 Are too Many Cooks Spoiling the Biosimilars Broth in

the UK? Dr Duncan Emerton, BioSimilarz

Room A Room B Room C Room DMaking Pharmaceuticals Seminar Programme

Register in Advance www.makingpharma.com

OPERATIONAL EXCELLENCE11.30 Operational Excellence: A Source of Competitive

Advantage? Dr Patrick McLaughlin, Cranfield University

11.50 Operational Excellence: Implications and Opportunities Dr Phil Warner, Cranfield University

12.10 Operational Excellence: Facing the Future Dr Nicola White, Cranfield University

14.00 Improved Process Understanding of Fluid Bed Granulation and Coating using Current PAT Solutions Luke Kiernan, Innopharmalabs

14.20 Automated Washing Principles and Common Mistakes Oliver Van Houtte, Steris

PHARMACEUTICAL QUALITY15.00 Supply Chain Risk Management – The Weakest Link

Steve Moss, Supply Chain, Pharmaceutical Quality Group15.20 Latest Developments in Packaging Materials GMP

Standard – PS 9000 David Abraham, Pharmaceutical Quality Group

15.40 Focus for Pharma Industry – Data Integrity Esme Gibb, Pharmaceutical Quality Group

27 April09.15 Metals Analytical Techniques for Pharmacopoeial

Compliance Reading Scientific Services Ltd (RSSL), Alan Cross

09.35 The Importance of Colour Measurement for the Pharmaceutical Industry Lovibond Tintometer, Elizabeth Wilkinson

09.55 Enhanced Sampling and Calibration Procedures for the Analysis of Residual Oxygen in Nitrogen Purged Pharmaceutical Packaging by GC-TCD Frank Judge, Butterworth Laboratories Ltd

Programme sponsored by: